Back to resultsBrazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia (DICA-HF)
Primary Purpose
Familial Hypercholesterolemia
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
phytosterol
krill oil
Placebo phytosterol
Placebo krill oil
Sponsored by
About this trial
This is an interventional treatment trial for Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria: Adult participants (age ≥20 years); Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria; Using one of the following treatment regimens for ≥ 6 weeks: simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40 - 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg. Exclusion Criteria: "Possible" diagnosis of FH according to the Dutch MEDPED criteria; Fasting triglycerides ≥ 500mg/dL; Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.); Food allergies (food, dyes, preservatives); Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia); HIV positive in treatment/AIDS; Chronic inflammatory diseases; Liver disease or chronic kidney disease on dialysis; Cancer under treatment or life expectancy < 6 months; Episode of acute coronary syndrome in the last 60 days; Chemical dependency/alcoholism; Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs; Use of PCSK9 inhibitors (alirocumab and evolocumab); Pregnancy or lactation; Wheelchair users unable to undergo anthropometric assessment; Body mass index ≥40kg/m²; Use of dietary supplements that may interfere with the outcomes of interest; Participation in other randomized clinical trials; Refusal to participate in the study.
Sites / Locations
- Hospital São José
- Hospital das Clínicas da Universidade Federal de Goiás
- Universidade Regional do Noroeste do Estado do Rio Grande do Sul
- Instituto Nacional de Cardiologia
- Hospital Ana Nery
- Universidade Feevale
- Hcor
- InCor
- Instituto Dante Pazzanese de Cardiologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
DICA-HF + placebo
DICA-HF + phytosterol
DICA-HF + krill oil
DICA-HF + phytosterol + krill oil
Arm Description
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days.
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
Outcomes
Primary Outcome Measures
LDL-c
Low-density lipoprotein cholesterol, in mg/dL
Lp(a)
Lipoprotein(a), in mg/dL
Adherence
Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).
Secondary Outcome Measures
TC
Total cholesterol, in mg/dL
HDL-c
High density lipoprotein cholesterol, in mg/dL
TG
Fasting triglycerides, in mg/dL
VLDL
Very low-density lipoprotein cholesterol, in mg/dL
NHDL
Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c
CI I
Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c
CI II
Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c
TG/HDL-c
TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c
AI
Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c
ox-LDL
Oxidized LDL, in µg/mL
AE
Adverse events (mild, moderate and severe), registered as percentage per study group
Implementation
Implementation components, measured by: on-time recruitment rates; choice and adjustments of remote platform/media for center sites training; measures of participants´ engagement to interventions; and rates of loss to follow-up.
Full Information
NCT ID
NCT05695937
First Posted
January 13, 2023
Last Updated
August 31, 2023
Sponsor
Hospital do Coracao
Collaborators
University of Sao Paulo, National Institute of Cardiology, Laranjeiras, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT05695937
Brief Title
Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
Acronym
DICA-HF
Official Title
Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: DICA-HF Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
University of Sao Paulo, National Institute of Cardiology, Laranjeiras, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this pilot study is to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) identified by the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ complete sequencing of the exome; to evaluate the effects of the interventions on lipid profile; to identify subclasses of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol; to perform untargeted lipidomic analyses; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate both implementation components and adherence rates to the protocol, aiming to design a larger randomized trial. In this pilot study, between 48 and 76 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to FH (DICA-HF) + phytosterol placebo + krill oil placebo (control group); 2) DICA-HF + 2g/day of phytosterol + krill oil placebo; 3) DICA-HF + phytosterol placebo + 2g/day of krill oil; and 4) DICA-HF + 2g/day of phytosterol + 2g/day of krill oil. Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up.
Detailed Description
DICA-HF pilot study is a superiority, factorial, and in parallel randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks of varying sizes stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 9 center sites in different Brazilian geographic regions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DICA-HF + placebo
Arm Type
Placebo Comparator
Arm Description
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days.
Arm Title
DICA-HF + phytosterol
Arm Type
Experimental
Arm Description
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.
Arm Title
DICA-HF + krill oil
Arm Type
Experimental
Arm Description
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days.
Arm Title
DICA-HF + phytosterol + krill oil
Arm Type
Experimental
Arm Description
Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
phytosterol
Intervention Description
2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.
Intervention Type
Dietary Supplement
Intervention Name(s)
krill oil
Intervention Description
2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.
Intervention Type
Other
Intervention Name(s)
Placebo phytosterol
Intervention Description
Placebo of phytosterol, in the same quantity of the active phytosterol
Intervention Type
Other
Intervention Name(s)
Placebo krill oil
Intervention Description
Placebo of krill oil, in the same quantity of the active krill oil
Primary Outcome Measure Information:
Title
LDL-c
Description
Low-density lipoprotein cholesterol, in mg/dL
Time Frame
120 days
Title
Lp(a)
Description
Lipoprotein(a), in mg/dL
Time Frame
120 days
Title
Adherence
Description
Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).
Time Frame
120 days
Secondary Outcome Measure Information:
Title
TC
Description
Total cholesterol, in mg/dL
Time Frame
120 days
Title
HDL-c
Description
High density lipoprotein cholesterol, in mg/dL
Time Frame
120 days
Title
TG
Description
Fasting triglycerides, in mg/dL
Time Frame
120 days
Title
VLDL
Description
Very low-density lipoprotein cholesterol, in mg/dL
Time Frame
120 days
Title
NHDL
Description
Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c
Time Frame
120 days
Title
CI I
Description
Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c
Time Frame
120 days
Title
CI II
Description
Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c
Time Frame
120 days
Title
TG/HDL-c
Description
TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c
Time Frame
120 days
Title
AI
Description
Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c
Time Frame
120 days
Title
ox-LDL
Description
Oxidized LDL, in µg/mL
Time Frame
120 days
Title
AE
Description
Adverse events (mild, moderate and severe), registered as percentage per study group
Time Frame
120 days
Title
Implementation
Description
Implementation components, measured by: on-time recruitment rates; choice and adjustments of remote platform/media for center sites training; measures of participants´ engagement to interventions; and rates of loss to follow-up.
Time Frame
120 days
Other Pre-specified Outcome Measures:
Title
Subfractions
Description
Subclasses of LDL-c and HDL-c, in mg/dL
Time Frame
120 days
Title
Lipidomics
Description
Analyses of untargeted lipidomic (all lipid species will be expressed in mg/dL)
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult participants (age ≥20 years);
Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
Using one of the following treatment regimens for ≥ 6 weeks: simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40 - 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.
Exclusion Criteria:
"Possible" diagnosis of FH according to the Dutch MEDPED criteria;
Fasting triglycerides ≥ 500mg/dL;
Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.);
Food allergies (food, dyes, preservatives);
Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
HIV positive in treatment/AIDS;
Chronic inflammatory diseases;
Liver disease or chronic kidney disease on dialysis;
Cancer under treatment or life expectancy < 6 months;
Episode of acute coronary syndrome in the last 60 days;
Chemical dependency/alcoholism;
Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs;
Use of PCSK9 inhibitors (alirocumab and evolocumab);
Pregnancy or lactation;
Wheelchair users unable to undergo anthropometric assessment;
Body mass index ≥40kg/m²;
Use of dietary supplements that may interfere with the outcomes of interest;
Participation in other randomized clinical trials;
Refusal to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Marcadenti, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana B Carvalho, PhD
Organizational Affiliation
Instituto Nacional de Cardiologia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexandre B Cavalcanti, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angela C Bersch-Ferreira, PhD
Organizational Affiliation
Real e Benemérita Associação Portuguesa de Beneficência
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabeth S Torres, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erlon O Abreu-Silva, MSc
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Geni R Sampaio, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julia P Krey, RDN
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karina L Negrelli, DVM
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis Gustavo S Mota, RDN
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo M Rogero, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Cristina Izar, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nagila T Damasceno, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrícia V de Luca, MSc
Organizational Affiliation
Associação Brasileira de Hipercolesterolemia Familiar
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro M Barros, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Renato N Santos, Stat
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rosana Perim, MSc
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thaís Martins, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital São José
City
Criciúma
Country
Brazil
Facility Name
Hospital das Clínicas da Universidade Federal de Goiás
City
Goiânia
Country
Brazil
Facility Name
Universidade Regional do Noroeste do Estado do Rio Grande do Sul
City
Ijuí
Country
Brazil
Facility Name
Instituto Nacional de Cardiologia
City
Rio De Janeiro
Country
Brazil
Facility Name
Hospital Ana Nery
City
Salvador
Country
Brazil
Facility Name
Universidade Feevale
City
São Leopoldo
Country
Brazil
Facility Name
Hcor
City
São Paulo
Country
Brazil
Facility Name
InCor
City
São Paulo
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
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